Lung CarcinomaNCT04922697
Educational Intervention for the Promotion of Knowledge and Preventive Health Behaviors Related to Personal Air Pollution Exposure, The Air Study
A study testing Educational Intervention and Questionnaire Administration in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure. Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 5 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years or older: The evidence for personal strategies to reduce air pollution exposure has been focused on adults
- Live in Seattle, WA: The study is designed to focus on Seattle, WA such as using EnviroFlash alerts
- Own a smartphone: The participant requires a smartphone to setup the Flow app for the air pollution sensor
- Not traveling in the near-term: The study is designed to assess air pollution patterns in the local Seattle area
- Leave your home for at least 7 hours per week: Participants will use a wearable air pollution sensor to measure air pollutant levels from indoor and outdoor sources
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Reducing PM2.5 Exposure and Lung Cancer Risk Using Spatial Data Science (The Air Study)
This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure. Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer. The educational intervention is comprised of 2 educational videos that include information regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure and the use of a wearable air pollution sensor. The knowledge gained from this study may inform future research that will be designed to promote awareness of air pollution and its health effects.
Read the detailed description
OUTLINE:
Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants complete questionnaires at weeks 1 and 5.
- Conditions
- Lung Carcinoma
- Being tested
- Educational Intervention, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch educational videos and use wearable air pollution sensor
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Prevention (educational videos, questionnaires) | Experimental | Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants will use wearable air pollution sensors. Participants will complete questionnaires at weeks 1 and 5. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knowledge regarding air pollution
Will calculate the proportion of the items that were answered correctly. McNemar's tests will be used to calculate differences in the proportion of participants answering air pollution knowledge items correctly at baseline and at week 5.
Measured: At baseline and week 5
Changes in air pollution preventive health behaviors
Will calculate summary scores for air pollution preventive health behaviors and paired t-test to determine intervention effectiveness at baseline and at week 5.
Measured: At baseline and week 5
Secondary outcomes (13)
Changes in perceived barriers
Summary scores for perceived barriers (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived barriers at baseline and week 5.
Measured: At baseline and week 5
Changes in perceived benefits
Summary scores for perceived benefits (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived benefits at baseline and week 5.
Measured: At baseline and week 5
Changes in perceived susceptibility
Summary scores for perceived susceptibility (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived susceptibility at baseline and week 5.
Measured: At baseline and week 5
Changes in perceived severity
Summary scores for perceived severity (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived severity at baseline and week 5.
Measured: At baseline and week 5
Changes in self-efficacy
Summary scores for self-efficacy (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in self-efficacy at baseline and week 5.
Measured: At baseline and week 5
Changes in cues to action
Will calculate frequencies for each cue to action (guided by the Health Belief Model). McNemar's tests will be used to calculate differences in the proportion of participants regarding each cue to action at baseline and week 5.
Measured: At baseline and week 5
Changes in air pollutant levels measured using the Flow 2 personal air quality sensor
Paired t-tests will determine changes in air pollutant levels at baseline and week 2 vs. week 4 and week 5.
Measured: At baseline and week 2 vs. week 4 and week 5
Intervention feasibility (accessibility)
Will report descriptive statistics for intervention accessibility based on responses to the relevant questionnaire items at week 5.
Measured: At week 5
Intervention feasibility (acceptability)
Will report descriptive statistics for intervention acceptability based on responses to the relevant questionnaire items at week 5.
Measured: At week 5
Intervention feasibility (demand)
Will report descriptive statistics for intervention demand based on responses to the relevant questionnaire items at week 5.
Measured: At week 5
Intervention feasibility (uptake, sensor upload completion)
Will report descriptive statistics the proportion of participants completing sensor uploads.
Measured: At baseline through week 5
Intervention feasibility (uptake, educational video viewing)
Will report descriptive statistics for the proportion of viewing educational videos at week 3.
Measured: At week 3
Intervention feasibility (uptake, questionnaire completion)
Will report descriptive statistics for the proportion of completing the questionnaires at baseline and week 5.
Measured: At baseline and week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start15 Sep 2021
- Primary completion10 Jan 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Trang VoPham, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922697
- Sponsor's protocol ID
- RG1121435
- Other IDs
- NCI-2021-04399, 10685
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing PM2.5 Exposure and Lung Cancer Risk Using Spatial Data Science (The Air Study)
- ClinicalTrials.gov ID
- NCT04922697
- Acronym / sponsor ID
- RG1121435
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure. Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer. The educational intervention is comprised of 2 educational videos that include information regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure and the use of a wearable air pollution sensor. The knowledge gained from this study may inform future research that will be designed to promote awareness of air pollution and its health effects.
Detailed description
OUTLINE:
Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants complete questionnaires at weeks 1 and 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (educational videos, questionnaires) | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationParticipants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants will use wearable air pollution sensors. Participants will complete questionnaires at weeks 1 and 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years or older: The evidence for personal strategies to reduce air pollution exposure has been focused on adults
- Live in Seattle, WA: The study is designed to focus on Seattle, WA such as using EnviroFlash alerts
- Own a smartphone: The participant requires a smartphone to setup the Flow app for the air pollution sensor
- Not traveling in the near-term: The study is designed to assess air pollution patterns in the local Seattle area
- Leave your home for at least 7 hours per week: Participants will use a wearable air pollution sensor to measure air pollutant levels from indoor and outdoor sources
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch educational videos and use wearable air pollution sensor | Other | Prevention (educational videos, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Prevention (educational videos, questionnaires) |
Primary outcome
Changes in knowledge regarding air pollution
Time frame: At baseline and week 5
Will calculate the proportion of the items that were answered correctly. McNemar's tests will be used to calculate differences in the proportion of participants answering air pollution knowledge items correctly at baseline and at week 5.
Changes in air pollution preventive health behaviors
Time frame: At baseline and week 5
Will calculate summary scores for air pollution preventive health behaviors and paired t-test to determine intervention effectiveness at baseline and at week 5.
13 secondary outcomes
Changes in perceived barriers
Time frame: At baseline and week 5
Changes in perceived benefits
Time frame: At baseline and week 5
Changes in perceived susceptibility
Time frame: At baseline and week 5
Changes in perceived severity
Time frame: At baseline and week 5
Changes in self-efficacy
Time frame: At baseline and week 5
Changes in cues to action
Time frame: At baseline and week 5
Changes in air pollutant levels measured using the Flow 2 personal air quality sensor
Time frame: At baseline and week 2 vs. week 4 and week 5
Intervention feasibility (accessibility)
Time frame: At week 5
Intervention feasibility (acceptability)
Time frame: At week 5
Intervention feasibility (demand)
Time frame: At week 5
Intervention feasibility (uptake, sensor upload completion)
Time frame: At baseline through week 5
Intervention feasibility (uptake, educational video viewing)
Time frame: At week 3
Intervention feasibility (uptake, questionnaire completion)
Time frame: At baseline and week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trang VoPham principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Questionnaire Administration in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in knowledge regarding air pollution (time frame: At baseline and week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.